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NCT Number: NCT06030947

Effectiveness of Micro Connective Tissue Graft for Treatment of Multiple Adjacent Gingival Recession Defects

The objective of this project is to evaluate 1-year outcomes of treatment of MAGRD using a modified coronally advanced tunnel technique (MCAT) with either conventional CTG (control group) or micro-CTG (test group).

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Confident Dubai Palm

Dubai, 0000, United Arab Emirates

Location status: Recruiting

Location contact

Olivier Carcuac, PhD

CONTACT

[email protected]

0556275575 ext. 00971

About this study

Gingival recession defects (GRD) present as a partial exposure of the root surface resulting from gingival margin displacement apical to the cemento-enamel junction (CEJ). A variety of surgical methods have been reported to reestablish root coverage, including tunneling techniques and coronally and laterally advanced flaps. As the presence of thin gingival tissues is one of the predisposing factors for GRD, the adjuvant use of subepithelial connective tissue grafts (CTGs) during the surgical correction is often considered. CTGs are thought to contribute to phenotype modification and stability of treatment outcomes and studies have indicated favorable esthetic results and high degrees of root coverage (documented range: 69% to 97%). The procedure does, however, require a suitable donor site. When multiple adjacent teeth exhibit GRDs, the preferred surgical approach should offer the greatest possible root coverage, while limiting drawbacks (i.e., patient morbidity, esthetic problems). Thus, one of the challenges related to coverage of multiple GRDs is the scarcity of donor tissue. In cases when large CTGs are required, additional surgical procedures may even be necessary. As an alternative, a modification of the harvested CTG into multiple "micro-CTGs" is proposed for the treatment of multiple adjacent GRDs (MAGRD). In the present study, the effectiveness and predictability of micro-CTGs will be evaluated in direct comparison to conventional CTGs.

The investigators hypothesise that no statistically significant differences will be observed in terms of % root coverage (primary outcome) and patient satisfaction at 12 months (non-inferiority).

The investigators hypothesise that subjects in the test group (micro-CTG) will report significantly lower morbidity at 1 and 2 weeks post-surgery when compared to controls (superiority).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥18 years,
  • systemically healthy,
  • presenting with a minimum of 4 and a maximum of 6 adjacent RT1/RT2 recessions, located in the maxilla or mandible with an apico-coronal extension (i.e. recession depth) of ≥2 mm,
  • Full-Mouth Plaque Score (FMPS) <20%,
  • Full-Mouth Bleeding Score (FMBS) <20%.

Exclusion criteria

  • pregnancy or lactation,
  • tobacco smoking,
  • uncontrolled medical condition,
  • medication that can affect gingival conditions.
  • thick phenotype,
  • severe tooth malpositioning,
  • uncorrected trauma from toothbrushing,
  • a previous history of root coverage procedures
  • the presence of furcation defects.

Treatment and study plan

Coronally Advanced Flap combined with a Connective Tissue Graft

Procedure

Multiple adjacent gingival recession defects will be covered by coronally advanced flap combined with a connective tissue graft harvested from the palate.

Coronally Advanced Flap combined with micro Connective Tissue Graft

Procedure

Multiple adjacent gingival recession defects will be covered by coronally advanced flap combined with multiple micro connective tissue graft harvested from the palate.

Division of the Connective Tissue Graft into multiple micro Connective Tissue Grafts

Device

The harvested connective tissue graft is divided in multiple micro connective tissue grafts with a scalpel blade before being placed on the recipient site.

Primary outcomes

  1. Mean mid-facial recession coverage (mRC)

    Time frame: up to 1 year

    Percentage of the exposed tooth root covered after surgical intervention

Secondary outcomes

  1. Complete Root Coverage (CRC)

    Time frame: up to 1 year

    Frequency of complete root coverage

  2. Changes of Keratinized Tissue Width (KTW)

    Time frame: up to 1 year

    Measured as the distance from the muco-gingival-junction to the gingival margin

  3. Changes of Gingival Thickness (GT)

    Time frame: up to 1 year

    Measured 3 mm apically from the free gingival margin at the mid-buccal aspect of the tooth

  4. Patient Morbidity

    Time frame: up to 2 weeks

    Measured with Visual Analogue Scale (VAS), which consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')

  5. Patient Satisfaction

    Time frame: up to 1 year

    Measured with Visual Analogue Scale (VAS), which consists of a 10cm line, with two end points representing 0 ('not satisfied') and 10 ('satisfied as much as it could possibly be')

Study contacts

Contact information is provided by the study sponsor or research team.

Jan Derks, DDS, PhD

CONTACT

[email protected]

317863124 ext. 0046

Olivier Carcuac, DDS, PhD

CONTACT

[email protected]

556275575 ext. 00971

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

Tunnel Surgery Combined With a Micro Connective Tissue Graft for the Treatment of Multiple Adjacent Gingival Recession Defects: a Multi-center Randomized Controlled Clinical Trial.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2023
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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